Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development.

Recent patient-centric regulatory and related initiatives are transforming the form and function of the pharmacovigilance function within the biopharmaceutical industry.

To meet this patient-centric imperative successfully, pharmacovigilance departments will need to develop a more patient-centered culture, use a framework-driven approach to patient engagement and become proficient in a range of patient-centered competencies.